Cleared Traditional

Pleurx Pleural Catheter System

K160450 · Care Fusion · Anesthesiology
Oct 2016
Decision
256d
Days
Class 2
Risk

About This 510(k) Submission

K160450 is an FDA 510(k) clearance for the Pleurx Pleural Catheter System, a Apparatus, Suction, Patient Care (Class II — Special Controls, product code DWM), submitted by Care Fusion (Vernon Hills, US). The FDA issued a Cleared decision on October 31, 2016, 256 days after receiving the submission on February 18, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.5050.

Submission Details

510(k) Number K160450 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 2016
Decision Date October 31, 2016
Days to Decision 256 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code DWM — Apparatus, Suction, Patient Care
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5050

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